FDA Adverse Event
Malfunction
Summary report: N
SURGISTOOL
MDR report key: 2472367
·
Received February 22, 2012
Report
- Report Number
- 1831750-2012-01647
- Event Type
- Malfunction
- Date Received
- February 22, 2012
- Date of Event
- January 24, 2012
- Report Date
- January 24, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FZM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
TEE HANDLE.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE WRIST REST SUPPORT WELDMENT TEE HANDLE NEEDED TO BE REPLACED. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGISTOOL | SURGERY, STOOL | FZM | STRYKER MEDICAL | 0830 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |